Biomea Fusion announces FDA, Health Canada clearance of COVALENT-111 study

Biomea Fusion announced FDA and Health Canada clearance of the expansion portion of the ongoing COVALENT-111 Phase II study. The objective of the expansion portion is to continue to investigate BMF-219 with treatment durations up to 12 weeks. Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board, commented, “We are excited to begin the expansion portion of COVALENT 111. It is an important milestone as the data from this trial will further inform development plans and our discussions with the FDA and Health Canada.” He further added, “BMF-219 has continued to show durable HbA1c lowering even after the dosing period has ended, which helps validate the postulated mechanism of action for BMF-219 – the regeneration of beta cells – and supports the potential for disease modification of type 2 diabetes. The momentum of our study is continuing to build with new sites coming onboard quickly and enrollment surpassing internal expectations. We look forward to reporting results from this study in the coming year.” During the escalation phase of COVALENT-111, a total of 32 type 2 diabetes patients completed 4-weeks of dosing with BMF-219 to date. An additional 30 type 2 diabetes patients will complete the escalation phase with 4 weeks of BMF-219 dosing in Q4 2023. Biomea anticipates providing topline data from the escalation phase of COVALENT-111 later this year and a more detailed presentation at a medical conference in 2024.